Uses of Lidocaine and Hydrocortisone Rectal Cream and Gel:

• It is used to treat signs of hemorrhoids or rectal irritation.

What do I need to tell my doctor BEFORE I take Lidocaine and Hydrocortisone Rectal Cream and Gel?

• If you have an allergy to lidocaine, hydrocortisone, or any other part of lidocaine and hydrocortisone rectal cream and gel.
• If you are allergic to lidocaine and hydrocortisone rectal cream and gel; any part of lidocaine and hydrocortisone rectal cream and gel; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Fungal, TB (tuberculosis), or viral infection of the skin.
• If you have a cold sore or a genital herpes outbreak.

This is not a list of all drugs or health problems that interact with lidocaine and hydrocortisone rectal cream and gel.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take lidocaine and hydrocortisone rectal cream and gel with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Lidocaine and Hydrocortisone Rectal Cream and Gel?

• Tell all of your health care providers that you take lidocaine and hydrocortisone rectal cream and gel. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before you use other drugs or products on your skin.
• Do not scratch or rub the skin while it is numb. Do not let it get very hot or very cold.
• Do not use lidocaine and hydrocortisone rectal cream and gel for longer than you were told by your doctor.
• This medicine may cause harm if swallowed. If lidocaine and hydrocortisone rectal cream and gel is swallowed, call a doctor or poison control center right away.
• A severe blood problem called methemoglobinemia has happened with drugs like this one. The risk may be raised in people who have glucose-6-phosphate dehydrogenase (G6PD) deficiency, heart problems, or lung problems. The risk may also be raised while taking certain other drugs and in infants younger than 6 months of age. Tell your doctor if you have ever had methemoglobinemia.
• Use with care in children. Talk with the doctor.
• If you are 65 or older, use lidocaine and hydrocortisone rectal cream and gel with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Lidocaine and Hydrocortisone Rectal Cream and Gel) best taken?

Use lidocaine and hydrocortisone rectal cream and gel as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine is for rectal use only. Do not take lidocaine and hydrocortisone rectal cream and gel by mouth.
• Keep out of your nose and eyes (may burn).
• Wash your hands before and after use.
• Do not put on cuts, scrapes, or damaged skin unless the doctor tells you to.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Signs of methemoglobinemia like a blue or gray color of the lips, nails, or skin; a heartbeat that does not feel normal; seizures; very bad dizziness or passing out; very bad headache; feeling very sleepy; feeling tired or weak; or shortness of breath. This effect is rare but may be deadly if it happens.
• Signs of skin infection like oozing, heat, swelling, redness, or pain.
• Irritation where lidocaine and hydrocortisone rectal cream and gel is used.
• Very bad bleeding from rectum or rectal pain.

What are some other side effects of Lidocaine and Hydrocortisone Rectal Cream and Gel?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning or stinging.
• Redness.
• Change in color of skin.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Lidocaine and Hydrocortisone Rectal Cream and Gel?

• Store at room temperature. Do not freeze.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about lidocaine and hydrocortisone rectal cream and gel, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.